SEdative-Hypnotic Deprescribing Assisted by a Technology-Driven Insomnia InterVEntion (SEDATIVE)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Insomnia Severity Index (ISI) Change
研究概览
简要总结
Chronic insomnia is one of the most common health problems among Veterans and significantly impacts their health, function, and quality of life. Sedative-hypnotic medications are the most common treatment despite mixed effectiveness and are associated with numerous risks that can further impact Veteran function. An intervention combining evidence-based interventions for deprescribing sedative-hypnotics and behavioral interventions for insomnia (e.g., Cognitive Behavioral Therapy for Insomnia [CBT-I]) can help to optimize sleep and functional outcomes for Veterans with a desire to reduce or stop using these medications. Furthermore, by delivering these interventions through an easy to use and highly accessible digital platform can provide additional benefits to Veterans, especially those with limited time and access to engage in traditional in-person interventions. The Clinician Operated Assistive Sleep Technology (COAST) is an efficient, scalable, and adaptable platform that can help providers to reach more Veterans and provide evidence-based care that translates to improved health and function.
Aim 1: To assess the feasibility of recruiting Veterans with chronic sedative-hypnotic use to participate in a 12-week combined deprescribing and CBT-I intervention, delivered through the COAST digital platform.
Aim 2: To assess Veteran acceptability and usability of the COAST platform.
Aim 3: To assess change in Veteran sleep, sedative-hypnotic use, and function pre- to post-intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A Veteran receiving care at VA Pittsburgh Healthcare System
- •Active sedative-hypnotic medication use >14 days/month for >=3 months
- •A desire to reduce or stop using sedative-hypnotic medications
- •Access to a mobile device with internet
排除标准
- •A disorder that would impair participation (e.g., cancer, uncontrolled pain, severe depression)
- •A disorder that can be exacerbated by changes in sleep (e.g., seizure disorder, bipolar I disorder)
- •High risk of suicide
- •An active substance use disorder in past 6 months
结局指标
主要结局
Insomnia Severity Index (ISI) Change
时间窗: baseline (T0; week 0), post-treatment (T1; week 12), 3 month follow-up (T2; week 24)
Total score (0-28): no insomnia (0-7); sub-threshold (8-14); moderate (15-21); and severe insomnia (22-28). A reduction pre- to post-treatment/follow-up of 8 points (or more) indicate a treatment response and a post-treatment/follow-up score or 7 (or less) indicate remission.
Sedative-Hypnotic Medication Use Change
时间窗: baseline (T0; week 0), post-treatment (T1; week 12), 3 month follow-up (T2; week 24)
Change in dose % from baseline (T0; week 0) to post-treatment (T1; week 12) Change in dose % from baseline (T0; week 0) to 3-month follow-up (T2; week 24)
次要结局
- Sedative-Hypnotic Medication Cessation(post-treatment (T1; week 12), 3 month follow-up (T2; week 24))
- Sleep Diary - Sleep Onset Latency (SOL) Change(baseline (T0; week 0), post-treatment (T1; week 12), 3 month follow-up (T2; week 24))
- Sleep Diary - Wake After Sleep Onset (WASO) Change(baseline (T0; week 0), post-treatment (T1; week 12), 3 month follow-up (T2; week 24))
- Sleep Diary - Sleep Efficiency Change(baseline (T0; week 0), post-treatment (T1; week 12), 3 month follow-up (T2; week 24))
- Patient-Reported Outcomes Measurement Information System Adult Profile (PROMIS 29+2) Change(baseline (T0; week 0), post-treatment (T1; week 12), 3 month follow-up (T2; week 24))
- Patient-Reported Outcomes Measurement Information System Adult Profile (PROMIS 29+2) - PROMIS Preference (PROPr)(baseline (T0; week 0), post-treatment (T1; week 12), 3 month follow-up (T2; week 24))